BEUDAMED
    FDA Enforcement Class II Terminated

    SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

    Recall: Z-1099-2019 · Reported April 17, 2019

    Enforcement

    Recall Number
    Z-1099-2019
    Event ID
    82365
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LivaNova USA Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 17, 2019
    Initiation Date
    September 14, 2018
    Classification Date
    April 5, 2019
    Termination Date
    September 14, 2022
    Address
    14401 W 65th Way, N/A, Arvada, CO, 80004-3503, United States

    Description

    SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

    Reason

    For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).

    Code Info

    Serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.

    Distribution

    US Distribution to states of: IN, MO, and OH.

    Quantity

    6 devices